Introduction

Ground rules

Note

  • Safe space, and participation from all is encouraged.
  • Shared vision & common goal
  • Reach agreement between members of the group
  • Respectful dialogue between equals
  • ⏰ Short interventions only please!


What we won’t do

We will not make definitive decisions here and now:
Proposed structure and content will be defined by consensus after the WHO team have reviewed and addressed all comments.

We won’t discuss fine-grained decisions on variable coding or the structure of the data:
This is constrained by the WHO Global Clinical Platform.

We will not vote on specific variables:
The WHO team will use these discussions to support the trade-offs required to reach the lightweight end-product.

What next?

After the first meeting:

  • The WHO technical team will compile a new version of the Case Report Form (CRF) based on the discussions

    • Each discussion is happening twice to accommodate time zone differences

  • We may ask you to complete prioritisation surveys if there are difficult specific decisions

  • We will reconvene in a second meeting to iterate this discussion

  • Another meeting may be required to finalise and ensure consensus (not yet planned).

Final Goal


To develop a Case Report Form (CRF) to provide a harmonised, lightweight, and near real-time clinical surveillance system for dengue that enables facilities and national programmes to monitor clinical outcomes and support care quality improvement.

Intended use of the CRF

  • For patients admitted to a facility with clinical suspicion of dengue, with or without diagnostic confirmation, a lightweight CRF collected at exit from the clinical facility (or at one week, if sooner).



  • Aiming for 5 mins / patient average data capture time (≅ 25 variables) which capture:
    • baseline demographics;
    • parsimonious markers of severity (for example shock, platelet count);
    • process markers of clinical care which are amenable to quality improvement.



  • There is some flexibility in length, as some questions might prompt sub-questions i.e. would only be required in a smaller sub-cohort of patients.

The process: Steps Variable Selection

Note

  • Some variables have been identified as required by the WHO upon discussion with partners.
  • Some variables have proposed reorganisation / combination in order to reduce complexity.
  • The pre-meeting survey showed relative priorities for variables. It is used as a starting point for discussions!
    • Variables which were universally important or critical are provisionally marked for inclusion.
    • Variables which were important or critical for >40% of the respondents are marked for discussion.
    • Other variables are marked not for inclusion.

Qualitative criteria by which to judge variables

Represent a marker which is related to quality of care and is modifiable by an intervention:

Feasibility of capture:
- Available within 7 days to clinical staff.



Objectivity:
- Standardised definition and method of ascertainment.



Close to universally relevant:
- All settings.

Non-rare:
- Not designed for never events for example.



Discriminatory:

  • Likely to represent meaningful differences.

Variables marked as required

A priori:

  • Date of admission
  • Admission criteria
  • Age
  • Sex
  • Final diagnosis
  • Laboratory confirmation of aetiology
  • Outcome (at 7 days according to the protocol)
  • Date of outcome
  • Suspected or confirmed dengue at admission is inferred

Additional based on survey:

  • BP (diastolic/systolic)
  • Heart rate
  • Platelets
  • Hematocrit
  • Vaccinated for dengue
  • Shock

Variables discarded

Demographics

  • Race
  • Weight
  • Height
  • Current occupation or work environment
  • International travel prior to symptom onset
  • list country(ies) visited
  • Patient’s city of residence


Symptoms

  • Any ear, nose, eye or throat problem
  • Any vaginal problem
  • Cardiac abnormality
  • Chest pain
  • Diarrhoea
  • Fatigue or malaise
  • Headache
  • Joint/Muscle pain or aching
  • Loss of taste
  • Lymph node abnormality
  • Neurological abormality
  • Skin rash

Laboratory and Imagery:

  • APTT/INR/pt
  • Lymphocytes/Neutrophils
  • Other haematology results available
  • WCC total
  • Radiology results available
  • Xray Key findings


Diagnosis:

  • Arbovirus Type
  • Multiple Arbovirus Diagnoses


Treatments:

  • Paracetamol/acetaminophen
  • ECMO 

Variables with proposed reorganisation / combination

Variables marked for discussion

Variables Up for Discussion

Demographics/Baseline

  • Is the patient currently pregnant or was pregnant in the last 6 weeks?

Key Points From Expert Consultation:

  • Pregnancy: experts agreed to retain Pregnancy as a core variable.

Vitals

  • AVPU
  • Capillary refill ≥ 3 sec
  • GCS
  • Respiratory rate
  • SpO2
  • Temperature
  • Height/Weight

Key Points From Expert Consultation:

  • Level of consciousness: discussion on whether to retain AVPU or GCS as the preferred assessment tool.
  • Temperature: highlighted by one expert as an important parameter to include.
  • Shock assessment: capillary refill time and SpO₂ identified as relevant markers of shock.
  • Height/Weight: discussion on inclusion for BMI calculation and to define Obesity (see also comorbities).

Symptoms

  • Confusion or agitation
  • Fever
  • / Seizures
  • WHO Warning Signs
    • Abdominal pain
    • Persistent Vomiting
    • Tender abdomen
  • Signs of ascites and pleural effusion
  • Bleeding

Key Points From Expert Consultation:

  • Signs of ascites and pleural effusion: considered important, with discussion on the best way to capture these variables.
  • Fever: suggested for exclusion by some experts.
  • Seizures: suggested for exclusion by some experts due to difficulty/reliability of recollection.
  • WHO warning signs: could serve as an umbrella term to include persistent vomiting and abdominal pain; importance of balancing feasibility, accuracy, and clinical relevance was emphasized.
  • Bleeding: discussion on whether to include as a symptom.

Comorbidities

  • Diabetes (type 1 or type 2)
  • Chronic heart disease (e.g., heart failure, coronary artery disease)
  • Chronic kidney disease
  • Chronic liver disease
  • Immunosuppressive condition or Immunosuppressive medication
  • Cancer diagnosis
  • Bleeding disorder or take anticoagulant/antiplatelet medication
  • Hypertension (HTA)

Key Points From Expert Consultation:

  • Obesity: discussion on inclusion; also noted the need to retain height and weight for BMI calculation in vitals.
  • Prematurity: suggested for consideration in pediatric patients, though not deemed critical by all experts.
  • Hypertension (HTA): recommended to be added as a comorbidity and moved out of the complications section.
  • Chronic disease: noted challenges in reliable recollection by participants.
  • Cancer: considered for exclusion by some experts

Laboratory and Imagery

  • Hemoglobin
  • Creatinine
  • Blood count results available
  • DENV serotype
  • Hematocrit

Key Points From Expert Consultation:

  • DENV serotype: considered important, though acknowledged as not available in all settings.
  • Hemoglobin: experts noted that hematocrit may be a better marker, being less affected by potential hemoconcentration.
  • Creatinine: considered important for defining AKI.
  • Availability of blood count results: suggested for exclusion by some experts.

Complications

  • Severe Organ Impairment
    • Respiratory Complications:
      • Acute Respiratory Distress Syndrome (ARDS)
    • Cardiac Complications:
      • Cardiac arrest
      • Cardiac arrhythmia
      • Myocarditis / Pericarditis
    • Liver Complications:
      • Acute hepatitis
      • Hepatic encephalopathy (any grade)
      • Severe liver disease (new onset)
    • Renal Complications:
      • Acute renal injury / Acute renal failure
      • Urine flow rate
    • Neurological Complications:
      • Encephalitis / Meningitis
      • Focal neurological signs
  • Fluid Overload
    • Pleural effusion / Ascites
  • Hypertension
  • Seizure
  • Sepsis
  • Severe bleeding

Key Points From Expert Consultation:

  • Severe Organ Impairment: suggested reclassification under the umbrella term Severe Organ Impairment for variables related to liver dysfunction, cardiac complications, and brain injury.
  • Fluid overload: suggested reclassification under the umbrella term Fluid overload for variables such as pleural effusion and ascites.
  • Seizure: suggested for exclusion by some experts.

Treatments

  • Blood transfusion
  • Platelets
  • Antivirals
  • Fluid drainage (Therapeutic ascitic/pleural tap included)
  • Highest level of respiratory support received
  • Renal replacement therapy (e.g., dialysis)
  • NSAIDs

Key Points From Expert Consultation:

  • Antivirals: suggested for exclusion by some experts.
  • Fluid drainage (Therapeutic ascitic/pleural tap included): There was discussion the need to keep as not done in every settings. Use of Diuretic was also mentioned.
  • NSAIDs: In addition to NSAIDs, Paracetamol was mentioned as a possible cause of liver dysfunction

Variables Not for Discussion

Vaccinations

Important

Variables below are considered Core of the WHO Clinical data platform and are not to be discussed as part of this process.


  • Vaccinated for dengue

Diagnosis

Important

Variables below are considered Core of the WHO Clinical data platform and are not to be discussed as part of this process.


  • Dengue virus infection
  • DENV PCR

Outcome

Important

Variables below are considered Core of the WHO Clinical data platform and are not to be discussed as part of this process.


  • Outcome at discharge
  • Date of discharge/transfer

Final Diagnosis

Important

Variables below are considered Core of the WHO Clinical data platform and are not to be discussed as part of this process.


  • Main diagnosis dengue?
  • Select Primary diagnosis if it is not Dengue
  • If no: What was the main diagnosis?
  • Final Clinical Inclusion Criteria
  • Type of Primary diagnosis

Thank you